U.S. Food and Drug Administration today approved a new indication for the
LifeVest wearable cardioverter defibrillator. The LifeVest is approved for
certain children who are at risk for sudden cardiac arrest, but
are not candidates for animplantable defibrillator due to certain medical conditions or
lack of parental consent.
many automated external defibrillators (which require a second person to
operate them) have been cleared for use in children, LifeVest is the only one
worn by the patient and monitors the heart continuously for abnormal,
life-threatening heart rhythms (arrhythmias). LifeVest
responds automatically if it senses the need to deliver a shock, restoring a
pediatric medical community is often forced to use adult devices off-label
without appropriate labeling or instructions for use in pediatric patients,”
saidVasum Peiris, M.D., M.P.H., Chief
Medical Officer of Pediatrics and Special Populations in the FDA’s Center for
Devices and Radiological Health. “Doctors now have important information that
may help them safely prescribe this life-saving device to young patients who
may benefit from the device.”
life-threatening abnormal heart rhythm, referred to as ventricular fibrillation
(V-fib) or ventricular tachycardia (V-tach), is the most common cause of sudden
cardiac arrest, according to the National Heart, Lung and Blood Institute.
Certain diseases and conditions that can lead to sudden cardiac arrest include
heart disease, certain inherited disorders and structural changes in the heart
(such as those due to infection or congenital heart disease). Most people who
have sudden cardiac arrest will die from it, often within minutes. Rapid
treatment with a defibrillator can save lives.
less than two pounds, the device consists of two main components: an electrode
belt and garment that surround the patient’s chest, and a monitor that the
patient wears around his or her waist. This device is intended only for
children that weigh at least 41 pounds and have a chest size of 26 inches or
more, about the size of an average 8 year old.
device was first approved in 2001 for patients 18 years of age and older. Later
models of the device were approved for patients 18 years of age and older in
2002, 2006 and 2009.
pediatric approval was based on published studies and a company registery
containing clinical information from 248 patients, ages 3 to 17, at risk for
sudden cardiac arrest. No additional safety concerns were identified, and
four patients who experienced sudden cardiac arrest received a shock that
successfully restored a life-sustaining heartbeat.
LifeVest defibrillator is manufactured by the ZOLL Manufacturing Corporation
based in Pittsburgh, Pennsylvania.
FDA, an agency within the U.S. Department of Health and Human Services, protects
the public health by assuring the safety, effectiveness, and security of human
and veterinary drugs, vaccines and other biological products for human use, and
medical devices. The agency also is responsible for the safety and security of
our nation’s food supply, cosmetics, dietary supplements, products that give
off electronic radiation, and for regulating tobacco products.